Parexel Blog
Parexel Blog
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Learn MoreVirus Filtration: a key manufacturing step keeping medicines safe, including from emerging viruses like COVID-19
Virus retentive filters are filters used in biotechnology and plasma derived product drug substance manufacturing for the specific purpose of physically removing potential viruses from...
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Learn MorePerspective on Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency
In summary FDA is moving quickly to implement emergency use applications (EUAs) policy to provide flexibility to those manufacturers of face masks and respirators to meet the need of medical...
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Learn MoreNew version 2 “The guidance on the management of clinical trials during COVID-19 (Coronavirus) pandemic” published on European Commission we
After only one week since publishing of the first version on 20-Mar-2020, an updated version 2 of “The guidance on the management of clinical trials during COVID-19 (Coronavirus) pandemic” has...
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Learn MoreNew global frameworks for managing clinical trials during COVID-19 emergency
As global health authorities react and adjust to responding to the emerging COVID-19 threat to public health, one of the results has been more guidance, published much more often and without going...
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Learn MoreWhere Do We Stand with COVID-19?
Since the first case of coronavirus (COVID-19) was identified in December 2019, cases have been confirmed on every continent but Antarctica, prompting the World Health Organization to declare...
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Learn MoreBack To The Future – Are You Prepared To Meet Unprecedented Demand to Use Old Drugs for New Purposes?
There has been significant momentum to begin repurposing existing drugs to find either prophylactic or acute treatments for COVID-19. These activities could result in further strains on...
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Learn MoreCOVID-19 pandemic and regulatory guidelines on clinical trial conduct; similarities and differences between regions
Introduction Multiple global regulatory authorities have issued guidances and blogs to assist sponsors in managing and planning for the impact of the COVID-19 pandemic specifically on ongoing...
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Learn MoreFDA creates new temporary policy on the preparation of hand sanitizer products
In Summary The FDA is moving quickly to implement temporary Guidance to provide flexibility to those pharmacies and compounding centers to produce sanitizing solutions required to meet...
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Learn MoreCOVID-19: Regulatory Impact
The COVID-19 pandemic is suddenly and unexpectedly presenting us with a unique moment in history. In a time of global crisis and desperate human suffering, the world needs treatments and...
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Learn MoreFDA Takes Action to Accelerate Availability of COVID-19 Diagnostic Tests
In summary: In a direct and timely action to address the acute shortage of diagnostic tests currently available to test for COVID-19 disease, the FDA has issued a new policy that enables both...
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Learn MoreDesk-based Health Authority Inspections: A Risk-based Approach to Compliance
Increasingly over the last 10 years global regulators have looked to see how a greater reliance on desk-based inspection activities can support their surveillance programs. This approach can be...
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Learn MoreSafer Technologies Program for Medical Devices (STeP): Initial Impressions
On September 19, 2019, the FDA issued a draft guidance on the Safer Technologies Program for Medical Devices (STeP), which was created as a complement to the Breakthrough Devices Program. Similar...
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Learn MoreThe Parexel Podcast | Episode 7: International Women’s Day - Insights from Ascending Davos
In this episode, Parexel Executive Vice President and Chief Commercial & Strategy Officer Peyton Howell interviews Meghan FitzGerald, Parexel Board Advisor and author of the new book Ascending...
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Learn MoreUnderstanding Department of Justice Enforcement Policies relating to FDA-Regulated Products
At the recent 2019 Enforcement, Litigation and Compliance Conference hosted by the Food and Drug Law Institute (see here), Deputy Assistant Attorney General David Morrell delivered the...
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Learn MoreThe Parexel Podcast | Episode 6: The opportunity for biotechs in precision medicine
Within the past 20 years, the field of precision medicine has been transformed. For biotech companies, this new landscape holds tremendous promise for innovation. So, why aren’t more...
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Learn MoreWhat Influences the Compliance Culture at FDA?
The Office of Compliance (OC) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) is a large organization. It has hundreds of personnel who are...
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Learn MoreRegulatory Blog | Bioprocessing and Biologics risk from Coronavirus
Coronavirus COVID-19 has been all over the news recently. This virus is part of a larger family called Coronaviridae, which includes viruses that can infect only animals, cause mild colds...
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Learn MoreCAR-T: How far have we come and where are we going?
In this episode, Doug Olson, one of the first CAR-T patients treated on a clinical trial for CLL almost 10 years ago, details his experiences with this therapy in its earliest days....
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Learn MoreFDA & Nitrosamine Impurities – The Proverb of the King with Long Arms
If the dictionary is to be believed, the expression that kings have long arms was first listed as a proverb in 1539 (see here). Over time it has developed into the commonly recognized idea...
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Learn MoreReflections on Cancer Drug Development Strategies with Newly-Introduced Chinese Regulations
The global cancer drug market is set to maintain strong growth over the next decade due to factors such as environmental pollution, population aging, and poor lifestyles that leave...
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